August 23, 2013
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Tenofovir disoproxil fumarate (tenofovir DF) can cause serious, life-threatening side effects. These include lactic acidosis (buildup of acid in your blood) and severe liver problems.
Contact your health care provider right away if you have any of the following symptoms that may signal lactic acidosis:
Contact your health care provider right away if you have any of the following symptoms that may signal severe liver problems:
If you have hepatitis B virus (HBV) infection and take tenofovir DF and then stop using it, you may have worsening of your HBV infection. Tell your health care provider about any new or unusual symptoms after you stop taking tenofovir DF.
While taking tenofovir DF, it is important to keep all of your appointments with your health care provider.
Tenofovir DF is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults and children 2 years of age and older. Tenofovir DF is always used in combination with other anti-HIV medicines.
Tenofovir DF is a type of anti-HIV medicine called a nucleoside reverse transcriptase inhibitor (NRTI). NRTIs work by blocking HIV reverse transcriptase, an HIV enzyme. This prevents HIV from replicating and lowers the amount of HIV in the blood.
Tenofovir DF does not cure HIV/AIDS. It is not known if tenofovir DF reduces the risk of passing HIV to other people.
Tenofovir DF is also an HBV reverse transcriptase inhibitor, approved by the FDA for the treatment of chronic HBV in adults and children 12 years of age and older. HBV is an HIV-related opportunistic infection. An opportunistic infection is an infection that occurs more frequently or is more severe in people with weakened immune systems -- such as those infected with HIV -- than in people with healthy immune systems.
The Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents, prepared by the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the HIV Medicine Association of the Infectious Diseases Society of America (IDSA-HIVMA), includes recommendations on the use of tenofovir DF to treat HBV infection in people who are also receiving combination antiretroviral therapy (ART) for HIV infection.
Before taking tenofovir DF, tell your health care provider:
Tenofovir DF comes in the following forms and strengths:
Take tenofovir DF according to your health care provider's instructions.
Tenofovir DF tablets should be swallowed whole and can be taken with or without food. People who are unable to swallow the tablets whole may take the oral powder. Use the provided dosing scoop to measure the oral powder. Mix the oral powder with soft foods that can be swallowed without chewing, such as applesauce, baby food, or yogurt. Take the dose of oral powder right after mixing it. Do not mix the oral powder with liquid.
Always take tenofovir DF in combination with other anti-HIV medicines.
If you take too much tenofovir DF, contact your local poison control center (1-800-222-1222) or go to the nearest hospital emergency room right away.
For more information on how to take tenofovir DF, see the FDA drug label from DailyMed. (DailyMed is a federal website that includes the most recent drug labels submitted to FDA.)
Take the missed dose as soon as you remember it. But if it is almost time for your next dose, skip the missed dose and just take your next dose at the regular time. Do not take two doses at the same time to make up for a missed dose.
Tenofovir DF can cause severe side effects. These include lactic acidosis (buildup of acid in your blood) and severe liver problems. (See the WARNING above.)
Other possible side effects of tenofovir DF include:
Tell your health care provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of tenofovir DF. Ask your health care provider or pharmacist for more information on possible side effects of tenofovir DF.
More information about tenofovir DF is available:
The above Patient Version drug summary is based on the following FDA label(s): Powder, tablet (coated).